Scientist/Sr. Scientist/Principal Scientist

CHEManager International; Exton (PA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health and Dental Insurance

401(k)

Disability Insurance

Life Insurance

Job summary

Frontage Laboratories is expanding its API GMP kilo-lab capabilities and seeks a Senior/Principal Scientist to lead route scouting, process optimization, scale-up and GMP batch support for small-molecule APIs. This hands-on role brings technical leadership with potential advancement to Associate Director.

You will design scalable routes, optimize reactions, contribute to CMC documentation, and mentor junior chemists while collaborating with QA, QC, and engineering on client programs.

Qualifications

• MS or PhD in Organic Chemistry with significant industry experience in process chemistry or pharmaceutical development.
• Experience in multi-step organic synthesis, route design, and scale-up.
• GMP manufacturing support knowledge and kilo-lab operations familiarity.
• Strong analytical data interpretation and process safety awareness.
• Proven ability to communicate with cross-functional teams and clients.

Responsibilities

• Lead process development and scale-up for small-molecule APIs and intermediates.
• Perform reaction optimization, impurity profiling, and robustness studies.
• Provide GMP kilo-lab technical support and assist kilogram-scale campaigns.
• Draft batch records, process descriptions, and support CMC documentation.
• Act as technical lead for client programs and oversee timelines.

Skills

Organic synthesis

Route design

Process optimization

Impurity control

Scale-up

GMP manufacturing support

Kilo-lab operations

Analytical data interpretation

Process safety

Cross-functional communication

Education

MS in Organic Chemistry

PhD in Organic Chemistry

Tools

Kilo-lab equipment

Pilot-plant equipment

Job description

Senior/Principal Scientist - Process Chemistry

Senior/Principal Scientist - Process Chemistry

Discovery Chemistry & API GMP Kilo-Lab

Location

Exton, PA

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position Summary

Frontage Laboratories is expanding its API GMP capabilities to support early- and mid-phase development programs for global biotech, pharmaceutical, and academic partners. We are seeking an experienced Process Chemistry Scientist to lead route scouting, process optimization, scale-up, and GMP batch support for small-molecule APIs. This is a hands-on laboratory role with technical leadership responsibilities and potential advancement to Associate Director, depending on experience.

Key Responsibilities

• Process Development & Scale-Up
• Design, develop, and optimize scalable synthetic routes for small-molecule APIs and intermediates.
• Conduct reaction optimization, impurity profiling, and robustness studies.
• Execute demonstration/engineering batches and support kilogram-scale manufacturing campaigns.
• GMP Kilo-Lab Technical Support
• Contribute to batch record drafting, process descriptions, and execute support kilogram-scale manufacturing campaigns.
• Provide on-the-floor technical support during non-GMP and GMP campaigns.
• Troubleshoot process deviations and equipment issues in real time.
• Collaborate with QA, QC, CMC Operations, EHS, and Engineering.
• Client Interaction & Project Leadership
• Serve as the technical point-of-contact for client programs.
• Present data clearly, propose development strategies, and manage timelines.
• Support CMC planning, risk mitigation, and tech-transfer discussions.
• Documentation & Regulatory
• Prepare process development reports, tech-transfer packages, and supporting CMC documentation.
• Ensure full compliance with non-GMP & GMP requirements and contribute to IND process sections.
• Team & Capability Development
• Mentor junior chemists and contribute to building best practices in the new kilo-lab.
• Support implementation of SOPs, equipment capabilities, and continuous improvement initiatives.
• Participate in hiring and onboarding as the group expands.

Qualifications (Flexible For Senior Scientist - Associate Director)

• Advanced degree (MS or PhD) in Organic Chemistry, or related field, with significant industry experience in process chemistry, CRO/CDMO, or pharmaceutical development.
• Strong hands-on expertise in multi-step organic synthesis, route design, process optimization, impurity control, and scale-up.
• Working understanding of kilo-lab or pilot-plant operations and GMP manufacturing support.
• Experience with analytical data interpretation and process safety considerations.
• Demonstrated ability to effectively communicate with cross-functional teams and external clients.
• Proven leadership ability - ranging from mentoring peers (Senior Scientist) to providing strategic program direction (Principal Scientist / Associate Director).
• Ability to thrive in a fast-paced CRO environment with multiple concurrent client programs.

Salary And Benefits

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.